# K210126: Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%

- Pathway: 510(k) (Traditional)
- Applicant: The Ritedose Corporation
- Decided: Dec 3, 2021 after 318 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K841988 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101424: Pharmacaribe Inhaled Saline Solutions, Pharmacaribe (2010) Summary page 4.

## Indications for use
Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 3%, 3.5%, 7%, and 10%.

Source page: https://510kreport.com/device/K210126
Methodology: https://510kreport.com/methodology